ABCL-452 First-Line Treatment With Subcutaneous Epcoritamab + R-CHOP in Patients With High-Risk Diffuse Large B-Cell Lymphoma (DLBCL): Phase 1/2 Data Update

Lorenzo Falchi, Fritz Offner, David Belada, Joshua Brody, Kim M. Linton, Yasmin Karimi, Raul Cordoba, Sylvia Snauwaert, Aqeel Abbas, Liwei Wang, Jun Wu, Brian Elliott, Michael Roost Clausen

Research output: Contribution to journalArticlepeer-review


Context: Patients with newly diagnosed high-risk DLBCL have suboptimal outcomes. Subcutaneous epcoritamab is a CD3xCD20 bispecific antibody well suited for combination with standard of care therapies. Objective: Evaluate safety and efficacy of epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in previously untreated patients with high-risk DLBCL in arm 1 of a phase 1/2, open-label trial (EPCORE NHL-2; NCT04663347). Patients: Adults with previously untreated CD20+ DLBCL and IPI ≥3 were included. As of December 1, 2021, 33 patients (median age, 66 y) had enrolled. Interventions: Patients received subcutaneous epcoritamab (QW, cycles 1–4; Q3W, cycles 5–6) + R-CHOP for 6 cycles (21 d) followed by epcoritamab monotherapy Q4W up to 1 y (in cycles of 28 d). Step-up dosing and corticosteroid prophylaxis were required. Results: All 33 patients treated (epcoritamab 24 mg, n=4; 48 mg, n=29) had IPI ≥3, and ≥24% had double/triple-hit DLBCL. Median follow-up was 3 mo (range, 0–9.7), median number of total cycles initiated was 5 (1–13), and 94% of patients (31/33) remained on treatment. Treatment-emergent AEs (TEAEs) in ≥35% of patients were neutropenia (48%; febrile neutropenia in 9% of all patients), CRS (45%), infections (42%), anemia (39%), and injection-site reactions (36%). No TEAEs led to epcoritamab discontinuation. Most CRS events were low grade (42% grade [G] 1–2, 3% G3), occurred in cycle 1, and resolved after a median of 2 d (1–11); 4 patients received tocilizumab. G2 ICANS occurred in 1 patient. No fatal TEAEs occurred. In efficacy-evaluable patients, the overall response rate (ORR) was 96% (24/25); 68% (17/25) had complete metabolic response (CMR) by PET-CT. In the 10 patients who completed 6 cycles of R-CHOP by the cutoff date, ORR and CMR rate were 100% and 90%, respectively; all patients remained in response at data cutoff (longest duration of response, 7.1+ mo, ongoing). Conclusions: Epcoritamab + R-CHOP had manageable safety, mostly low-grade CRS that did not lead to treatment discontinuation, and high response rates in patients with previously untreated DLBCL. Updated data will be presented. Funding: This study was funded by Genmab A/S and AbbVie.

Original languageEnglish
Pages (from-to)S380
JournalClinical Lymphoma, Myeloma and Leukemia
StatePublished - Oct 2022


  • ABCL
  • Phase I/II
  • bispecific
  • diffuse large B-cell lymphoma
  • hematologic malignancy
  • non-Hodgkin lymphoma


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